HRP Services
Compliance Assessments, Audits
HRP Consulting is frequently asked to assist organizations by providing an independent assessment of investigator, committee, or program compliance with regulatory or accreditation standards. Whether routine QA or for-cause, comprehensive or targeted, or an evaluation of inspection or accreditation readiness, HRP is prepared to help.
FDA Announces ClinicalTrials.Gov Enforcement Action
FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements. While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including...
Institutional Review Board: Management and Function
Institutional Review Board: Management and Function” is now available through the Jones & Bartlett Learning website. Ms. Savini, Ms. Christianson, and Ms. Matuk of HRP Consulting were honored to contribute content for this book, casually referred to as the “IRB...